Clinical Trial: NCT05728268
Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Status:
RECRUITINGPhase:
Phase 2| Lead Sponsor: | Shantou Central Hospital |
| Information Provided By: | Shantou Central Hospital |
| Last Update Posted: | 2026-01-02 |
Study Overview
Brief Summary
Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.
Official Title
Conditions
Intervention / Treatment
- Drug: dose-dense nab-paclitaxel followed by EC
Other Study ID Numbers
- ShantouCH02
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Estimated)
Enrollment (Estimated)
Study Type
Phase
| Lead Sponsor: | Shantou Central Hospital |
| Information Provided By: | Shantou Central Hospital |
| Last Update Posted: | 2026-01-02 |
Study Overview
Brief Summary
Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.
Official Title
Conditions
Intervention / Treatment
- Drug: dose-dense nab-paclitaxel followed by EC
Other Study ID Numbers
- ShantouCH02